CurrentCignaPolicy N/A

Vijoice Prior Authorization Policy

Prior authorization policy for Vijoice (alpelisib tablets and oral granules) for treatment of PIK3CA-Related Overgrowth Spectrum (PROS) in patients ≥2 years of age, describing initial and continuation approval criteria, duration of approval, and exclusions.

Policy Summary

PayerCigna

PolicyVijoice Prior Authorization Policy

Policy CodePolicy N/A

Change TypeFormulation added; annual revisions noted

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Vijoice; approvals are provided for specified durations based on initial (6 months) versus continuation (1 year) criteria.

POLICY UPDATE CHANGES

Vijoice oral granules were added to the policy; same criteria for tablets applies to oral granules formulation.

Annual revisions with no criteria changes recorded on multiple dates.

1Covered Indication (PROS)

>=2Minimum Age (years)

6m/1yApproval Durations (initial/continuation)

Coverage Summary

Scope: This prior authorization policy covers Vijoice (alpelisib tablets and oral granules) for treatment of PIK3CA-Related Overgrowth Spectrum (PROS) in patients aged ≥ 2 years who require systemic therapy. Coverage is provided as covered_with_criteria when the specified clinical criteria are met.

Coverage rules: For initial therapy the policy requires the patient be ≥ 2 years of age, have at least one severe clinical manifestation of PROS as determined by the prescriber, have a confirmed PIK3CA mutation by genetic testing, and the medication be prescribed by or in consultation with a physician who specializes in genetic disorders. If approved under Initial Therapy, authorize for 6 months.

Continuation: For patients currently receiving Vijoice, the policy requires the patient have been established on Vijoice for at least 6 months, have experienced a reduction in lesion volume from baseline in at least one lesion (measurement-confirmed), and have experienced improvement in at least one sign or symptom of PROS from baseline. If approved under Continuation, authorize for 1 year.

Key thresholds

Minimum age>= 2 years

Initial approval duration6 months

Continuation approval duration1 year

Established therapy requirement>= 6 months on Vijoice prior to review under continuation criteria

Radiologic response definitionReduction in volume from baseline in at least one lesion (measurement-confirmed); pivotal study defined radiologic response as >=20% reduction in sum of measurable target lesion volume at Week 24 without >=20% increase in any target lesion or new/progressing lesions.

Conditions Not Covered / Exclusions

Conditions Not Covered: The policy includes a section header for conditions not covered but does not list any specific non-covered conditions. No explicit exclusions beyond the stated criteria for initial and continuation therapy are provided in the brief.

Provider Actions / Authorization & Documentation

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Vijoice (alpelisib tablets and oral granules). Approvals are provided for specified durations based on whether the request is for initial therapy (approve for 6 months) or for continuation in a patient currently receiving Vijoice (approve for 1 year).

Documentation Required

Genetic testing confirmation

For initial therapy requests, providers must document confirmation of a PIK3CA mutation by genetic testing.

Documentation Required

Severity and manifestations documentation

For initial therapy, the prescriber must document that the patient has at least one severe clinical manifestation of PROS as determined by the prescriber. Examples of severe clinical manifestations include excessive tissue growth, blood vessel malformations, scoliosis, vascular tumors, cardiac or renal manifestations, and those who require systemic treatment.

Documentation Required

Response documentation for continuation

For continuation (patients currently receiving Vijoice), providers must document a reduction in volume from baseline in at least one lesion confirmed by measurement, and an improvement in at least one sign or symptom of PROS from baseline.

Documentation Required

Specialist involvement

For initial therapy, the medication must be prescribed by or in consultation with a physician who specializes in treatment of genetic disorders.

Clinical Evidence

27%Pivotal trial response rate — 27% (10/37) radiological response at Week 24

70%Duration of response ≥6 months — 70% of responders

60%Duration of response ≥12 months — 60% of responders

Background evidence: Efficacy is based on a single-arm pivotal study conducted in patients with PROS (≥ 2 years old with severe manifestations requiring systemic therapy) that demonstrated a radiologic response rate of 27% (10/37) at Week 24 and clinically meaningful improvements in PROS-related signs and symptoms. The indication was approved under accelerated approval.

Background & Definitions

Vijoice is a PI3K inhibitor approved under accelerated approval for the treatment of severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) in adults and pediatric patients ≥ 2 years of age who require systemic therapy. Evidence supporting approval comes from a single-arm pivotal study. The policy was updated to explicitly include the oral granules formulation with the same criteria as tablets.

Definition of PROS: PIK3CA-Related Overgrowth Spectrum (PROS) is a heterogeneous group of disorders caused by PIK3CA mutations, characterized by congenital or early-childhood onset of segmental/focal overgrowth and associated vascular and lymphatic malformations, often with asymmetric involvement of brain, limbs, trunk, and face and a range of potential complications.

Revision History

06/19/2024material_change

Selected revision: Vijoice oral granules were added to the policy; same criteria for tablets applies to oral granules formulation.

05/10/2023review

Annual revision with no criteria changes recorded.

05/15/2024review

Annual revision with no criteria changes recorded.

05/07/2025reviewLatest

Annual revision with no criteria changes recorded.

Policy Summary

PayerCigna

PolicyVijoice Prior Authorization Policy

Policy CodePolicy N/A

Change TypeFormulation added; annual revisions noted

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Vijoice; approvals are provided for specified durations based on initial (6 months) versus continuation (1 year) criteria.

On This Page

OpenPayer

Vijoice Prior Authorization Policy

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Conditions Not Covered / Exclusions

Applicable Codes

Provider Actions / Authorization & Documentation

Clinical Evidence

Background & Definitions

Revision History